(28 days)
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy. The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat. The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated. For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user. The ATMOS Scope is delivered in a non-sterile condition.
The provided text describes the ATMOS Scope, a flexible nasopharyngo laryngoscope, and its equivalence to a predicate device (Schoelly CMOS Video Nasopharyngoscope System K143673). However, the document does not contain information typically associated with acceptance criteria and a study design for evaluating the diagnostic performance of a medical device using an AI component.
Instead, the provided text focuses on demonstrating substantial equivalence through comparisons of technical characteristics and various non-clinical performance tests. These tests are primarily related to safety, functionality, and manufacturing compliance, rather than diagnostic accuracy or effectiveness in a clinical context that would require a human-in-the-loop or standalone AI performance study.
Therefore, I cannot directly answer your questions in the requested format as the provided document does not include such a study or information.
Here's what I can extract based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance or reported performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various technical parameters and confirms successful testing against standards.
| Acceptance Criteria Category | Reported Device Performance Summary |
|---|---|
| Indications for Use | "ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor." (Identical to predicate) |
| Design | Flexible and steerable fiberoptic endoscope for diagnostic purposes (Identical to predicate) |
| Material | Handle: aluminum; Insertion tube: PEEK, FKM, TPU, sapphire glass (Identical to predicate) |
| Chip-on-Tip | CMOS image sensor at the tip of the insertion tube (Identical to predicate) |
| Illumination | LED (2 LEDs) (Identical to predicate) |
| Deflection | 2 x 135° (Identical to predicate) |
| Weight | 0.4 kg (Identical to predicate) |
| USB Connection | Yes (Identical to predicate, though direct connection to PC vs. via CCU is a difference) |
| Focus Range | 6 - 60 mm (Identical to predicate) |
| Delivery Status | Non-sterile (Identical to predicate) |
| Image Sensor Resolution | 1280 x 800 pixels (Higher than predicate's 328 x 250 pixels); Justification: provides optimized view, not a negative impact on safety/effectiveness. |
| Field of view | 90° (Larger than predicate's 85°); Justification: provides optimized view, not a negative impact on safety/effectiveness. |
| Stroboscopy | Not supported (Removed feature from predicate due to patient complaints). |
| Sterilization | Validated for Low-Temperature Hydrogen Peroxide Gas Sterilization and SYSTEM 1E® Liquid Chemical Sterilant Processing System (differs from predicate's ethylene oxide); Validation tests performed according to FDA recognized standards. |
| Reprocessing | Manual cleaning with MetriZyme™ or Cidezyme, and manual high-level disinfection with CIDEX® OPA (differs from predicate's listed solutions); Validation performed by AAMI TIR 30: 2011 and ASTM E 1837-96 (2014). |
| Human Factors | Successfully tested regarding dimensions (length, diameter, deflection/angle) and requirements for basic safety and essential performance of endoscopic equipment per IEC 60601-2-18. Ergonmics of patient and user interfaces are equivalent to the predicate device. |
| Optical Performance & Photobiological Safety | Evaluation per IEC 62471:2006, LEDs classified in risk group 2. Measurements prove photobiological safety and no risk/hazard from light source. |
| Biocompatibility | Evaluation performed to comply with ISO 10993-1:2018 and FDA Guidance Documents. Effectiveness confirmed. |
| Electrical Safety & EMC | Tests performed per IEC 60601-1:2005 (Electrical Safety) and IEC 60601-1-2 Edition 4.0 2014-02 (EMC). All risk-based requirements and acceptance criteria were defined and met. |
| Software V&V | Embedded software does not provide support for basic safety or essential performance. Failure does not lead to risk. All firmware functions validated; requirements traceability matrix documented. USB connection checked for configuration, device name, and live image broadcast. All firmware tests passed successfully. |
| Labeling | In compliance with ANSI ISO 15223-1 3rd edition 2016-11-01. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical performance and safety testing. There is no mention of a test set for diagnostic performance or data provenance for such a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set for diagnostic performance or experts establishing ground truth. The device provides "visualization via a monitor" for "visual diagnostics by the user," implying human interpretation, but no study is detailed to quantify this diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The ATMOS Scope is a visualization device, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a direct visualization tool. There is no AI algorithm component described for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study requiring ground truth is described.
8. The sample size for the training set
Not applicable. There is no mention of an AI component or a training set for machine learning.
9. How the ground truth for the training set was established
Not applicable. No AI component or training set is mentioned.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.